{"protocolSection":{"identificationModule":{"nctId":"NCT03078075","orgStudyIdInfo":{"id":"CTN-0068"},"secondaryIdInfos":[{"id":"UG1DA020024","type":"NIH","link":"https://reporter.nih.gov/quickSearch/UG1DA020024"}],"organization":{"fullName":"University of Texas Southwestern Medical Center","class":"OTHER"},"briefTitle":"Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder","officialTitle":"NIDA (National Institute on Drug Abuse) CTN (Clinical Trials Network) Protocol 0068: Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder","acronym":"ADAPT-2"},"statusModule":{"statusVerifiedDate":"2021-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-05-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-07-03","type":"ACTUAL"},"completionDateStruct":{"date":"2019-07-25","type":"ACTUAL"},"studyFirstSubmitDate":"2017-03-02","studyFirstSubmitQcDate":"2017-03-10","studyFirstPostDateStruct":{"date":"2017-03-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-12-31","resultsFirstSubmitQcDate":"2021-03-02","resultsFirstPostDateStruct":{"date":"2021-03-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-04-06","lastUpdatePostDateStruct":{"date":"2021-05-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Madhukar H. Trivedi, MD","investigatorTitle":"Professor","investigatorAffiliation":"University of Texas Southwestern Medical Center"},"leadSponsor":{"name":"University of Texas Southwestern Medical Center","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"},{"name":"The Emmes Company, LLC","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.","detailedDescription":"There will be 400 adults with moderate or severe methamphetamine use disorder randomized into this multi-site study. Eligibility will be determined during a maximum 21 day screening period. After screening is completed and eligibility is confirmed, including successful administration of a naloxone challenge, participants will begin the 12 week medication phase of the trial. Participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching placebo (PLB) arm and receive injections of placebo (iPLB) plus once-daily oral placebo (oPLB) tablets. During the course of the study, participants may be switched to another arm, as determined by the a priori adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched. Overall, approximately 50% of the participants will receive the AMC. Injections will be administered every three weeks, in weeks 1, 4, 7, and 10. Take-home oral study medication (BUP-XL or oPLB) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend the clinic twice weekly for observed oral medication dosing, assessments, collection of urine samples, and once-weekly medical management. On non-clinic days, participants will participate in smartphone app-based medication adherence activities. Participants will be asked to complete assessments as indicated on the schedule of assessments. Following the 12 week medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visits during weeks 13 and 16."},"conditionsModule":{"conditions":["Methamphetamine Use Disorder"],"keywords":["Methamphetamine","Methamphetamine Use Disorder","Naltrexone","Bupropion","Vivitrol®"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","interventionModelDescription":"During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":403,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Active Medication Combination (AMC)","type":"EXPERIMENTAL","description":"injectable extended release naltrexone plus once daily oral extended-release bupropion tablets","interventionNames":["Drug: Naltrexone: Vivitrol®","Drug: Bupropion: Wellbutrin XL®"]},{"label":"Matched Placebo (PLB)","type":"PLACEBO_COMPARATOR","description":"injectable matching placebo plus once-daily oral placebo tablets","interventionNames":["Drug: Placebo (PLB) Injectable","Drug: Placebo (PLB) Oral"]}],"interventions":[{"type":"DRUG","name":"Naltrexone: Vivitrol®","description":"Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks","armGroupLabels":["Active Medication Combination (AMC)"],"otherNames":["Arm: Experimental - Active Medication Combination (AMC)"]},{"type":"DRUG","name":"Placebo (PLB) Injectable","description":"Placebo: 4 intramuscular injections administered every 3 weeks","armGroupLabels":["Matched Placebo (PLB)"],"otherNames":["Injectable matching (to Naltrexone) placebo","Arm: Placebo Comparator - matched Placebo (PLB)"]},{"type":"DRUG","name":"Bupropion: Wellbutrin XL®","description":"Bupropion: 450 mg oral dose daily","armGroupLabels":["Active Medication Combination (AMC)"],"otherNames":["Arm: Experimental - Active Medication Combination (AMC)"]},{"type":"DRUG","name":"Placebo (PLB) Oral","description":"Placebo: once-daily oral placebo tablets","armGroupLabels":["Matched Placebo (PLB)"],"otherNames":["Oral matching (to Bupropion) placebo tablets","Arm: Placebo Comparator - matched Placebo (PLB)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment Response During Medication Phase at Stage 1","description":"Treatment response is defined as 'Responder' and 'Non-Responder'.\n\nResponder : Participant who meet responder criterion by providing at least 3 out of a possible 4 methamphetamine-negative urine tests at the end of stage 1 (weeks 5-6).\n\nNon-Responder: All other participants without 3 or 4 methamphetamine-negative UDS (Urine Drug Screen).","timeFrame":"At weeks 6"},{"measure":"Number of Participants With Treatment Response During Medication Phase at Stage 2","description":"Treatment response is defined as 'Responder' and 'Non-Responder'.\n\nResponder : Participant who meet responder criterion by providing at least 3 out of a possible 4 methamphetamine-negative urine tests at the end of stage 1 (weeks 5-6).\n\nNon-Responder: All other participants without 3 or 4 methamphetamine-negative UDS.","timeFrame":"At week 12"}],"secondaryOutcomes":[{"measure":"Treatment Effectiveness Score of Participants at Stage 1","description":"The Treatment Effectiveness Score (TES) as measured by UDS results, during the treatment period. The TES is the percentage of the expected urine drug screens that were negative for each drug. Twelve urine drug screens are expected within each stage.","timeFrame":"At weeks 6"},{"measure":"Treatment Effectiveness Score of Participants at Stage 2","description":"The Treatment Effectiveness Score (TES) as measured by UDS results, during the treatment period. The TES is the percentage of the expected urine drug screens that were negative for each drug. Twelve urine drug screens are expected within each stage. The range of possible scores are 0-100 and higher score indicates better outcomes.","timeFrame":"At week 12"},{"measure":"Percentage of Participants Who Used Methamphetamine in the Pre-evaluation Period","description":"Methamphetamine use, as measured by UDS (urine drug screen) in the pre-evaluation period (Weeks 1-4 for Stage 1 and Weeks 7-10 for Stage 2 )","timeFrame":"Weeks 1-4 and Weeks 7-10"},{"measure":"Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1","description":"Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number.","timeFrame":"At week 6"},{"measure":"Mean Maximum Number of Consecutive Visits Negative UDS at Stage 2","description":"Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the maximum number.","timeFrame":"Stage 2 evaluation period at Weeks 12"},{"measure":"Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1","description":"Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS.","timeFrame":"At week 6"},{"measure":"Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2","description":"Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS.","timeFrame":"At week12"},{"measure":"Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1","description":"Methamphetamine use selfreported on TLFB ( Timeline Followback) during the follow-up period.\n\nThe baseline measure is the percentage of abstinent days in the 30 days prior to randomization. The outcome is the change in percentage of abstinent days.","timeFrame":"Baseline, week 6"},{"measure":"Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2","description":"Methamphetamine use selfreported on TLFB ( Timeline Followback) during the follow-up period.\n\nThe baseline measure is the percentage of abstinent days in the 30 days prior to randomization. The outcome is the change in percentage of abstinent days.","timeFrame":"week 7, week 12"},{"measure":"Mean Change of Methamphetamine Craving at Stage 1","description":"Severity of methamphetamine craving, as measured by Visual Analog Craving Scales (VAS), during the treatment period. VAS scores range from 0 (no craving) to 100 (most intense craving possible). The VAS is completed at screening, once a week during the treatment period, and at the follow-up visits.","timeFrame":"Baseline, week 6"},{"measure":"Mean Change of Methamphetamine Craving at Stage 2","description":"Severity of methamphetamine craving, as measured by Visual Analog Craving Scales (VAS), during the treatment period. VAS scores range from 0 (no craving) to 100 (most intense craving possible). The VAS is completed at screening, once a week during the treatment period, and at the follow-up visits.","timeFrame":"week 7, week 12"},{"measure":"Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1","description":"Other substance use including Amphetamine, Non-Methamphetamine Drug, Cocaine, Alcohol, Cigarettes, as measured by UDS, during the treatment period. Opioid use will also be assessed using the Opioid 2000 ng tests on the UDS.","timeFrame":"At week 6"},{"measure":"Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2","description":"Other substance use including Amphetamine, Non-Methamphetamine Drug, Cocaine, Alcohol, Cigarettes, as measured by UDS, during the treatment period. Opioid use will also be assessed using the Opioid 2000 ng tests on the UDS.","timeFrame":"at week 12"},{"measure":"Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1","description":"Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period.","timeFrame":"Baseline, week 6"},{"measure":"Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2","description":"Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period.","timeFrame":"week 7, week 12"},{"measure":"Mean Change in Number of Other Substance Use by Self-report at Stage 1","description":"Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period.","timeFrame":"Baseline, week 6"},{"measure":"Mean Change in Number of Other Substance Use by Self-report at Stage 2","description":"Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period.","timeFrame":"week 7, week 12"},{"measure":"Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1","description":"Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 1.","timeFrame":"Baseline, week 6"},{"measure":"Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2","description":"Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 2.","timeFrame":"week 7, week 12"},{"measure":"Mean Change of Depression Symptom Score by PHQ-9 at Stage 1","description":"Patient Health Questionnaire-9 (PHQ-9) measures participants depression symptoms. Possible scores range from 0-27, with higher scores indicating a more severe depression symptoms.\n\nPHQ-9 scores reflect depression severity, ranges from 0-27 (0 no depressive symptoms, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression)","timeFrame":"Baseline, week 6"},{"measure":"Mean Change of Depression Symptom Score by PHQ-9 at Stage 2","description":"Patient Health Questionnaire-9 measures participants depression symptoms. Possible scores range from 0-27, with higher scores indicating a more severe depression symptoms.\n\nPHQ-9 scores reflect depression severity, ranges from 0-27 (0 no depressive symptoms, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression)","timeFrame":"week 7, week 12"},{"measure":"Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1","description":"Mean change score of QOL (General health, Physical health, and Mental health) from baseline will be assessed by PhenX (Phenotypes and eXposures) Core Tier 1 instrument: Quality of Life (QOL), which measures participants' quality of life during the past 30 days. Possible scores range from 0 to 30 (number of days in the past 30 in which health was good), with higher scores indicating a better quality of life.","timeFrame":"Baseline, Week 6"},{"measure":"Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2","description":"Mean change score of QOL (General health, Physical health, and Mental health) from baseline will be assessed by PhenX Core Tier 1 instrument: Quality of Life (QOL), which measures participants' quality of life during the past 30 days. Possible scores range from 0 to 30 (number of days in the past 30 in which health was good), with higher scores indicating a better quality of life.","timeFrame":"week 7, week 12"},{"measure":"Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1","description":"The Treatment Effectiveness Assessment is a 4-item self-administered assessment that uses a Likert scale (1-10) to document changes in four life domains: substance use, health, lifestyle, and community and is collected at screening, mid-treatment (Week 6 Visit 2) and end-of-treatment (Week 12 Visit 2).\n\nPossible scores range from 4-40, with higher scores indicating a higher overall functioning.","timeFrame":"Baseline, week 6"},{"measure":"Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2","description":"The Treatment Effectiveness Assessment is a 4-item self-administered assessment that uses a Likert scale (1-10) to document changes in four life domains: substance use, health, lifestyle, and community and is collected at screening, mid-treatment (Week 6 Visit 2) and end-of-treatment (Week 12 Visit 2).\n\nPossible scores range from 4-40, with higher scores indicating a higher overall functioning.","timeFrame":"week 7, week 12"},{"measure":"Number of Participants Who Completed the Visit in Week 12","timeFrame":"At week 12"},{"measure":"Participant Satisfaction Rating Measured by Study Satisfaction Survey at the End of the Study","description":"The Study satisfaction survey measures participants satisfaction. We do not have a proper score range (varied range with some free text questions also)","timeFrame":"At week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 18 to 65 years old;\n* Interested in reducing/stopping methamphetamine use;\n* Speak English;\n* Agree to use acceptable birth control (if applicable);\n* Be opioid-free at randomization;\n* Willing to comply with all study procedures and medication instructions;\n* Agree to use a cell phone (or similar study device) to take videos of medication dosing.\n\nExclusion Criteria:\n\n* Medical or psychiatric condition which would make participation unsafe;\n* Recently participated in a study of pharmacological or behavioral treatment for methamphetamine use disorder;\n* Recently taken an investigational drug;\n* Prescribed and taken naltrexone or bupropion ≤ 30 days from consent;\n* Current or planned extended absence during study period (e.g., jail, surgery, pending legal action);\n* Currently pregnant or breastfeeding.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Madhukar Trivedi, MD","affiliation":"University of Texas Southwestern Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of California Los Angeles (UCLA) Center for Behavioral Addiction Medicine (CBAM)","city":"Los Angeles","state":"California","zip":"90038","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Substance Use Research Unit (SURU) at the San Francisco Dept. of Public Health","city":"San Francisco","state":"California","zip":"94102","country":"United States","geoPoint":{"lat":37.77493,"lon":-122.41942}},{"facility":"Hennepin County Medical Center- Berman Center for Research","city":"Minneapolis","state":"Minnesota","zip":"55415","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"New York State Psychiatric Institute (NYSPI)- Substance Use Research Center (SURC)","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"CODA, Inc.","city":"Portland","state":"Oregon","zip":"97214","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Behavioral Health Services (BHS) of Pickens County","city":"Pickens","state":"South Carolina","zip":"29671","country":"United States","geoPoint":{"lat":34.88345,"lon":-82.70736}},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","zip":"75235","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Texas Health Science Center - Center for Neurobehavioral Research on Addiction (CNRA)","city":"Houston","state":"Texas","zip":"77054","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}}]},"referencesModule":{"references":[{"pmid":"42504048","type":"DERIVED","citation":"Mojtabai R, Susukida R, Farokhnia M, Nguyen TQ, Leggio L, Bergeria C, Prasad S, Dunn KE, Amin-Esmaeili M. Mediators of treatment response in a clinical trial of naltrexone and bupropion for methamphetamine use disorder: A longitudinal mediation analysis. J Psychopharmacol. 2026 Jul 26:2698811261464533. doi: 10.1177/02698811261464533. Online ahead of print."},{"pmid":"42180350","type":"DERIVED","citation":"Mojtabai R, Susukida R, Farokhnia M, Nguyen TQ, Leggio L, Bergeria C, Prasad S, Dunn KE, Amin-Esmaeili M. Mediators of Treatment Response in Clinical Trial of Naltrexone and Bupropion for Methamphetamine Use Disorder: A Longitudinal Mediation Analysis. medRxiv [Preprint]. 2026 May 13:2026.05.09.26352807. doi: 10.64898/2026.05.09.26352807."},{"pmid":"40767786","type":"DERIVED","citation":"Jha MK, Ghitza UE, Shoptaw S, Minhajuddin A, Kuruvila S, Wakhlu S, Nunes EV, Schmitz J, Coffin PO, Bart G, Carmody T, Trivedi MH. Early Change in Depressive Symptom Severity With Naltrexone-Bupropion Combination and Its Association With Reduction in Methamphetamine Use in ADAPT-2 Trial. J Clin Psychiatry. 2025 Jul 30;86(3):25m15825. doi: 10.4088/JCP.25m15825."},{"pmid":"40623319","type":"DERIVED","citation":"Jha MK, Ghitza UE, Carmody T, Kuruvila S, Shoptaw S, Minhajuddin A, Wakhlu S, Schmitz JM, Coffin PO, Bart G, Nunes EV, Kenny P, Trivedi MH. Craving, Impulsivity, and Subsequent Methamphetamine Use With Naltrexone-Bupropion Versus Placebo: Findings From a Randomized Clinical Trial. J Addict Med. 2026 Mar-Apr 01;20(2):214-222. doi: 10.1097/ADM.0000000000001538. Epub 2025 Jul 7."},{"pmid":"38856086","type":"DERIVED","citation":"Li MJ, Chau B, Belin T, Carmody T, Jha MK, Marino EN, Trivedi M, Shoptaw SJ. Extended observation of reduced methamphetamine use with combined naltrexone plus bupropion in the ADAPT-2 trial. Addiction. 2024 Oct;119(10):1840-1845. doi: 10.1111/add.16529. Epub 2024 Jun 10."},{"pmid":"38665252","type":"DERIVED","citation":"Okafor CN, Carmody T, Stotts AL, Bart G, Mayes TL, Karns-Wright T, Trivedi M, Shoptaw S, Potter JS. Sociodemographic and patient reported outcomes by racial and ethnicity status among participants in a randomized controlled trial for methamphetamine use disorder. Drug Alcohol Depend Rep. 2024 Apr 6;11:100230. doi: 10.1016/j.dadr.2024.100230. eCollection 2024 Jun."},{"pmid":"37377462","type":"DERIVED","citation":"Trombello JM, Kulikova A, Mayes TL, Nandy K, Carmody T, Bart G, Nunes EV, Schmitz J, Kalmin M, Shoptaw S, Trivedi MH. Psychometrics of the Concise Health Risk Tracking Self-Report (CHRT-SR16) Assessment of Suicidality in a Sample of Adults with Moderate to Severe Methamphetamine Use Disorder: Findings from the ADAPT-2 Randomized Trial. Neuropsychiatr Dis Treat. 2023 Jun 22;19:1443-1454. doi: 10.2147/NDT.S406909. eCollection 2023."},{"pmid":"37245855","type":"DERIVED","citation":"Vo HT, Kulikova A, Mayes TL, Carmody T, Shoptaw S, Ling W, Trombello JM, Trivedi MH. Psychometric properties of the Treatment Effectiveness Assessment in methamphetamine use disorder. J Subst Use Addict Treat. 2023 Aug;151:209085. doi: 10.1016/j.josat.2023.209085. Epub 2023 May 26."},{"pmid":"33497547","type":"DERIVED","citation":"Trivedi MH, Walker R, Ling W, Dela Cruz A, Sharma G, Carmody T, Ghitza UE, Wahle A, Kim M, Shores-Wilson K, Sparenborg S, Coffin P, Schmitz J, Wiest K, Bart G, Sonne SC, Wakhlu S, Rush AJ, Nunes EV, Shoptaw S. Bupropion and Naltrexone in Methamphetamine Use Disorder. N Engl J Med. 2021 Jan 14;384(2):140-153. doi: 10.1056/NEJMoa2020214."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All participants were randomized to either the AMC arm or the Placebo arm in Week 1; thus all are represented in the two Stage 1 categories (total 403).\n\nAll participants also are represented in Stage 2. Some participants were re-randomized at Week 7 and some were not; thus the four Stage 2 categories also total 403.","groups":[{"id":"FG000","title":"Stage 1 Placebo Non-responders Re-randomized to Placebo at Stage 2","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were non-responders at week 5 and 6, and then re-randomized to Placebo at stage 2."},{"id":"FG001","title":"Stage 1 Placebo Non-responders Re-randomized to AMC at Stage 2","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were non-responders at week 5 and 6, and then re-randomized to AMC at stage 2."},{"id":"FG002","title":"Stage 1 Placebo Non-responders Not Re-randomized at Stage 2","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were non-responders at week 5 and 6 and then not re-randomized at stage 2, remained in the Placebo arm."},{"id":"FG003","title":"Stage 1 Placebo Responders Not Re-randomized at Stage 2","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1) who were responders at week 5 and 6 and then not re-randomized at stage 2, remained in the Placebo arm."},{"id":"FG004","title":"Stage 1 AMC Remaining on AMC at Stage 2","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"114"},{"groupId":"FG002","numSubjects":"59"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"109"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"103"},{"groupId":"FG002","numSubjects":"19"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"78"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"40"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"31"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The Baseline characteristics are based on stage 1 assignment","groups":[{"id":"BG000","title":"Active Medication Combination (AMC)","description":"injectable extended release naltrexone plus once daily oral extended-release bupropion tablets\n\nNaltrexone: Vivitrol®: Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks\n\nBupropion: Wellbutrin XL® (Extended release): Bupropion: 450 mg oral dose daily"},{"id":"BG001","title":"Matched Placebo (PLB)","description":"injectable matching placebo plus once-daily oral placebo tablets\n\nPlacebo (PLB) Injectable: Placebo: 4 intramuscular injections administered every 3 weeks\n\nPlacebo (PLB) Oral: Placebo: once-daily oral placebo tablets"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"109"},{"groupId":"BG001","value":"294"},{"groupId":"BG002","value":"403"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41","spread":"10.6"},{"groupId":"BG001","value":"41","spread":"10.0"},{"groupId":"BG002","value":"41","spread":"10.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"126"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"199"},{"groupId":"BG002","value":"277"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Not Hispanic/ Latino","categories":[{"measurements":[{"groupId":"BG000","value":"96"},{"groupId":"BG001","value":"249"},{"groupId":"BG002","value":"345"}]}]},{"title":"Hispanic/Latino","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"55"}]}]},{"title":"Unknown Ethnicity","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}]},{"title":"Refused to answer Ethnicity","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]},{"title":"American Indian/Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"11"}]}]},{"title":"Black/ African American","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"48"}]}]},{"title":"Native Hawaiian/ Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"287"}]}]},{"title":"Other Race","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"20"}]}]},{"title":"Multiracial","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"16"}]}]},{"title":"Unknown Race","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}]}]},{"title":"Refused to answer Race","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment Response During Medication Phase at Stage 1","description":"Treatment response is defined as 'Responder' and 'Non-Responder'.\n\nResponder : Participant who meet responder criterion by providing at least 3 out of a possible 4 methamphetamine-negative urine tests at the end of stage 1 (weeks 5-6).\n\nNon-Responder: All other participants without 3 or 4 methamphetamine-negative UDS (Urine Drug Screen).","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At weeks 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"title":"Responders (Methamphetamine negative UDS 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Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"},{"id":"OG002","title":"Stage 2 Not Re-Randomized Placebo","description":"Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12)."},{"id":"OG003","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"109"}]}],"classes":[{"categories":[{"title":"Responders (Methamphetamine negative UDS results)","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"21"}]},{"title":"Non-Responders (Methamphetamine positive UDS results)","measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"101"},{"groupId":"OG002","value":"60"},{"groupId":"OG003","value":"88"}]}]}]},{"type":"SECONDARY","title":"Treatment Effectiveness Score of Participants at Stage 1","description":"The Treatment Effectiveness Score (TES) as measured by UDS results, during the treatment period. The TES is the percentage of the expected urine drug screens that were negative for each drug. Twelve urine drug screens are expected within each stage.","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of urine drug screens","timeFrame":"At weeks 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.72","spread":"13.41"},{"groupId":"OG001","value":"13.84","spread":"22.97"}]}]}]},{"type":"SECONDARY","title":"Treatment Effectiveness Score of Participants at Stage 2","description":"The Treatment Effectiveness Score (TES) as measured by UDS results, during the treatment period. The TES is the percentage of the expected urine drug screens that were negative for each drug. Twelve urine drug screens are expected within each stage. The range of possible scores are 0-100 and higher score indicates better outcomes.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of urine drug screens","timeFrame":"At week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 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the Placebo arm throughout the study (Weeks 1-12)."},{"id":"OG005","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"},{"groupId":"OG002","value":"111"},{"groupId":"OG003","value":"114"},{"groupId":"OG004","value":"69"},{"groupId":"OG005","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.10"},{"groupId":"OG001","value":"11.93"},{"groupId":"OG002","value":"7.95"},{"groupId":"OG003","value":"10.20"},{"groupId":"OG004","value":"29.46"},{"groupId":"OG005","value":"22.56"}]}]}]},{"type":"SECONDARY","title":"Mean Maximum Number of Consecutive Visits Negative UDS at Stage 1","description":"Measured by maximum consecutive negative UDS: Count the number and range 0-12 and report the 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number.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"UDS test results","timeFrame":"Stage 2 evaluation period at Weeks 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants randomized to the Placebo arm in Stage 2"},{"id":"OG001","title":"Stage 2 Re-Randomized AMC (Active Medication Combination Arm)","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 2"},{"id":"OG002","title":"Stage 2 Not Re-Randomized Placebo","description":"Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12)."},{"id":"OG003","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.61","spread":"1.46"},{"groupId":"OG001","value":"1.18","spread":"2.72"},{"groupId":"OG002","value":"3.10","spread":"4.39"},{"groupId":"OG003","value":"2.63","spread":"4.13"}]}]}]},{"type":"SECONDARY","title":"Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 1","description":"Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"weeks","timeFrame":"At week 6","groups":[{"id":"OG000","title":"Placebo","description":"Those participants randomized to the Placebo arm in Stage 1"},{"id":"OG001","title":"AMC (Active Medication Combination)","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.15","spread":"0.55"},{"groupId":"OG001","value":"0.56","spread":"1.20"}]}]}]},{"type":"SECONDARY","title":"Mean Number of Study Weeks With Two Methamphetamine-negative UDS at Stage 2","description":"Measured by the number of study weeks during the treatment period with two methamphetamine-negative UDS.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"weeks","timeFrame":"At week12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"},{"id":"OG002","title":"Stage 2 Not Re-Randomized Placebo","description":"Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12)."},{"id":"OG003","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.20","spread":"0.70"},{"groupId":"OG001","value":"0.50","spread":"1.35"},{"groupId":"OG002","value":"1.48","spread":"2.21"},{"groupId":"OG003","value":"1.20","spread":"2.08"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 1","description":"Methamphetamine use selfreported on TLFB ( Timeline Followback) during the follow-up period.\n\nThe baseline measure is the percentage of abstinent days in the 30 days prior to randomization. The outcome is the change in percentage of abstinent days.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of abstinent days","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.0","spread":"1.3"},{"groupId":"OG001","value":"27.2","spread":"2.88"}]}]}]},{"type":"SECONDARY","title":"Mean Change Percentage of Methamphetamine Abstinent Days Measured by Self-report at Stage 2","description":"Methamphetamine use selfreported on TLFB ( Timeline Followback) during the follow-up period.\n\nThe baseline measure is the percentage of abstinent days in the 30 days prior to randomization. The outcome is the change in percentage of abstinent days.","populationDescription":"These numbers come from a model which does not use the Stage 2 Not rerandomized data. As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of abstinent days","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16","spread":"1.5"},{"groupId":"OG001","value":"25.3","spread":"2.6"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Methamphetamine Craving at Stage 1","description":"Severity of methamphetamine craving, as measured by Visual Analog Craving Scales (VAS), during the treatment period. VAS scores range from 0 (no craving) to 100 (most intense craving possible). The VAS is completed at screening, once a week during the treatment period, and at the follow-up visits.","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-22.33","spread":"1.82"},{"groupId":"OG001","value":"-29.98","spread":"3.17"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Methamphetamine Craving at Stage 2","description":"Severity of methamphetamine craving, as measured by Visual Analog Craving Scales (VAS), during the treatment period. VAS scores range from 0 (no craving) to 100 (most intense craving possible). The VAS is completed at screening, once a week during the treatment period, and at the follow-up visits.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-20.52","spread":"1.72"},{"groupId":"OG001","value":"-31.79","spread":"3.17"}]}]}]},{"type":"SECONDARY","title":"Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 1","description":"Other substance use including Amphetamine, Non-Methamphetamine Drug, Cocaine, Alcohol, Cigarettes, as measured by UDS, during the treatment period. Opioid use will also be assessed using the Opioid 2000 ng tests on the UDS.","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"At week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Amphetamine","categories":[{"measurements":[{"groupId":"OG000","value":"41.89","spread":"1.0"},{"groupId":"OG001","value":"41.95","spread":"0.3"}]}]},{"title":"Non-Methamphetamine Drug","categories":[{"measurements":[{"groupId":"OG000","value":"28.53","spread":"14.7"},{"groupId":"OG001","value":"31.47","spread":"13.8"}]}]},{"title":"Cocaine","categories":[{"measurements":[{"groupId":"OG000","value":"41.87","spread":"0.6"},{"groupId":"OG001","value":"41.87","spread":"0.5"}]}]},{"title":"Alcohol","categories":[{"measurements":[{"groupId":"OG000","value":"36.44","spread":"9.5"},{"groupId":"OG001","value":"37.89","spread":"7.2"}]}]},{"title":"Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"15.29","spread":"18.7"},{"groupId":"OG001","value":"16.31","spread":"18.2"}]}]}]},{"type":"SECONDARY","title":"Mean Number of Abstinent Days of Participants Who Used Other Substance Measured by UDS at Stage 2","description":"Other substance use including Amphetamine, Non-Methamphetamine Drug, Cocaine, Alcohol, Cigarettes, as measured by UDS, during the treatment period. Opioid use will also be assessed using the Opioid 2000 ng tests on the UDS.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"at week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"title":"Amphetamine","categories":[{"measurements":[{"groupId":"OG000","value":"44.96","spread":"0.3"},{"groupId":"OG001","value":"44.95","spread":"0.3"}]}]},{"title":"Non-Methamphetamine drug","categories":[{"measurements":[{"groupId":"OG000","value":"30.99","spread":"15.2"},{"groupId":"OG001","value":"31.05","spread":"16.1"}]}]},{"title":"Cocaine","categories":[{"measurements":[{"groupId":"OG000","value":"44.9","spread":"0.4"},{"groupId":"OG001","value":"44.88","spread":"0.5"}]}]},{"title":"Alcohol","categories":[{"measurements":[{"groupId":"OG000","value":"38.41","spread":"11.9"},{"groupId":"OG001","value":"39.91","spread":"9.1"}]}]},{"title":"Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"17.11","spread":"20.0"},{"groupId":"OG001","value":"19.31","spread":"20.1"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 1","description":"Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"proportion of abstinent days","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Alcohol","categories":[{"measurements":[{"groupId":"OG000","value":"-0.054","spread":"0.011"},{"groupId":"OG001","value":"-0.016","spread":"0.017"}]}]},{"title":"Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"0.054","spread":"0.010"},{"groupId":"OG001","value":"0.103","spread":"0.021"}]}]},{"title":"E- Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"-0.064","spread":"0.009"},{"groupId":"OG001","value":"-0.072","spread":"0.016"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Proportion of Other Substance Abstinent Days Measured by Self-report at Stage 2","description":"Proportion of abstinent days of other substance including Alcohol, Cigarettes and E- Cigarettes was measured by self-report on TLFB during the treatment period.","populationDescription":"These numbers come from a model which does not use the Stage 2 Not rerandomized data. As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"proportion of abstinent days","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"title":"Alcohol","categories":[{"measurements":[{"groupId":"OG000","value":"-0.035","spread":"0.012"},{"groupId":"OG001","value":"-0.035","spread":"0.016"}]}]},{"title":"Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"0.038","spread":"0.012"},{"groupId":"OG001","value":"0.119","spread":"0.022"}]}]},{"title":"E- Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"-0.057","spread":"0.011"},{"groupId":"OG001","value":"-0.079","spread":"0.014"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Number of Other Substance Use by Self-report at Stage 1","description":"Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period.","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"substances","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Alcohol","categories":[{"measurements":[{"groupId":"OG000","value":"0.358","spread":"1.503"},{"groupId":"OG001","value":"-1.604","spread":"3.290"}]}]},{"title":"Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"-12.642","spread":"7.221"},{"groupId":"OG001","value":"-55.873","spread":"14.154"}]}]}]},{"type":"SECONDARY","title":"Mean Change in Number of Other Substance Use by Self-report at Stage 2","description":"Number of other substance (Alcohol and Cigarettes) use was measured by self-report recall on Timeline Followback (TLFB) during the treatment period.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). These numbers come from a model which does not use the Stage 2 Not rerandomized data so we do not have any estimates for the same.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"substances","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"title":"Alcohol","categories":[{"measurements":[{"groupId":"OG000","value":"1.695","spread":"1.779"},{"groupId":"OG001","value":"-2.942","spread":"3.121"}]}]},{"title":"Cigarettes","categories":[{"measurements":[{"groupId":"OG000","value":"-9.925","spread":"7.801"},{"groupId":"OG001","value":"-58.591","spread":"14.594"}]}]}]},{"type":"SECONDARY","title":"Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 1","description":"Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 1.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Proportion of abstinent days","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.064","spread":"0.009"},{"groupId":"OG001","value":"-0.072","spread":"0.016"}]}]}]},{"type":"SECONDARY","title":"Change in Proportion of E-cigarettes Abstinent Days by Self-report at Stage 2","description":"Proportion of abstinent days of E- Cigarettes was measured by self-report at stage 2.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Proportion of abstinent days","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.057","spread":"0.011"},{"groupId":"OG001","value":"-0.079","spread":"0.014"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Depression Symptom Score by PHQ-9 at Stage 1","description":"Patient Health Questionnaire-9 (PHQ-9) measures participants depression symptoms. Possible scores range from 0-27, with higher scores indicating a more severe depression symptoms.\n\nPHQ-9 scores reflect depression severity, ranges from 0-27 (0 no depressive symptoms, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression)","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.26","spread":"0.34"},{"groupId":"OG001","value":"-4.78","spread":"0.70"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Depression Symptom Score by PHQ-9 at Stage 2","description":"Patient Health Questionnaire-9 measures participants depression symptoms. Possible scores range from 0-27, with higher scores indicating a more severe depression symptoms.\n\nPHQ-9 scores reflect depression severity, ranges from 0-27 (0 no depressive symptoms, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression)","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.66","spread":"0.37"},{"groupId":"OG001","value":"-4.39","spread":"0.64"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 1","description":"Mean change score of QOL (General health, Physical health, and Mental health) from baseline will be assessed by PhenX (Phenotypes and eXposures) Core Tier 1 instrument: Quality of Life (QOL), which measures participants' quality of life during the past 30 days. Possible scores range from 0 to 30 (number of days in the past 30 in which health was good), with higher scores indicating a better quality of life.","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Physical Health","categories":[{"measurements":[{"groupId":"OG000","value":"1.013","spread":"0.805"},{"groupId":"OG001","value":"1.425","spread":"1.225"}]}]},{"title":"Mental Health","categories":[{"measurements":[{"groupId":"OG000","value":"1.071","spread":"0.842"},{"groupId":"OG001","value":"3.785","spread":"1.380"}]}]},{"title":"General Health","categories":[{"measurements":[{"groupId":"OG000","value":"-1.168","spread":"0.957"},{"groupId":"OG001","value":"1.582","spread":"1.442"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Quality of Life (QOL) by PhenX Core Tier 1 Instrument at Stage 2","description":"Mean change score of QOL (General health, Physical health, and Mental health) from baseline will be assessed by PhenX Core Tier 1 instrument: Quality of Life (QOL), which measures participants' quality of life during the past 30 days. Possible scores range from 0 to 30 (number of days in the past 30 in which health was good), with higher scores indicating a better quality of life.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"title":"Physical Health","categories":[{"measurements":[{"groupId":"OG000","value":"0.877","spread":"0.870"},{"groupId":"OG001","value":"1.561","spread":"1.147"}]}]},{"title":"Mental Health","categories":[{"measurements":[{"groupId":"OG000","value":"2.035","spread":"0.917"},{"groupId":"OG001","value":"2.821","spread":"1.345"}]}]},{"title":"General Health","categories":[{"measurements":[{"groupId":"OG000","value":"0.262","spread":"1.038"},{"groupId":"OG001","value":"0.152","spread":"1.365"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 1","description":"The Treatment Effectiveness Assessment is a 4-item self-administered assessment that uses a Likert scale (1-10) to document changes in four life domains: substance use, health, lifestyle, and community and is collected at screening, mid-treatment (Week 6 Visit 2) and end-of-treatment (Week 12 Visit 2).\n\nPossible scores range from 4-40, with higher scores indicating a higher overall functioning.","populationDescription":"Intention to treat analysis was done including drop-out","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, week 6","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"1.0"},{"groupId":"OG001","value":"6.5","spread":"1.5"}]}]}]},{"type":"SECONDARY","title":"Mean Change of Overall Functioning as Measured by Treatment Effectiveness Assessment (TEA) at Stage 2","description":"The Treatment Effectiveness Assessment is a 4-item self-administered assessment that uses a Likert scale (1-10) to document changes in four life domains: substance use, health, lifestyle, and community and is collected at screening, mid-treatment (Week 6 Visit 2) and end-of-treatment (Week 12 Visit 2).\n\nPossible scores range from 4-40, with higher scores indicating a higher overall functioning.","populationDescription":"As per study protocol, stage 2 secondary outcomes are reported for only re-randomized groups (Placebo and AMC). Data for Not Re-Randomized groups at stage 2 were not included for the main analysis, thus not reported","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"week 7, week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"1.1"},{"groupId":"OG001","value":"6.2","spread":"1.5"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Completed the Visit in Week 12","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 12","groups":[{"id":"OG000","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG001","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"},{"id":"OG002","title":"Stage 2 Not Re-Randomized Placebo","description":"Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12)."},{"id":"OG003","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"103"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"78"}]}]}]},{"type":"SECONDARY","title":"Participant Satisfaction Rating Measured by Study Satisfaction Survey at the End of the Study","description":"The Study satisfaction survey measures participants satisfaction. We do not have a proper score range (varied range with some free text questions also)","populationDescription":"We did not collect data about satisfaction.","reportingStatus":"POSTED","timeFrame":"At week 12","groups":[{"id":"OG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7."},{"id":"OG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."},{"id":"OG002","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7)."},{"id":"OG003","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)"},{"id":"OG004","title":"Stage 2 Not Re-Randomized Placebo","description":"Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12)."},{"id":"OG005","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to 12 weeks","eventGroups":[{"id":"EG000","title":"Stage 1 Placebo","description":"Those participants randomized to the Placebo arm in Stage 1 (Week 1); these participants may or may not be re-randomized in Week 7.","deathsNumAffected":0,"deathsNumAtRisk":294,"seriousNumAffected":4,"seriousNumAtRisk":294,"otherNumAffected":45,"otherNumAtRisk":294},{"id":"EG001","title":"Stage 1 AMC","description":"Those participants who were randomized to the Active Medication Combination arm in Stage 1 (Study Week 1) remained in the AMC arm throughout the study (Weeks 1-12).","deathsNumAffected":0,"deathsNumAtRisk":109,"seriousNumAffected":1,"seriousNumAtRisk":109,"otherNumAffected":41,"otherNumAtRisk":109},{"id":"EG002","title":"Stage 2 Re-Randomized Placebo","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Placebo arm in Stage 2 (Week 7).","deathsNumAffected":0,"deathsNumAtRisk":111,"seriousNumAffected":4,"seriousNumAtRisk":111,"otherNumAffected":8,"otherNumAtRisk":111},{"id":"EG003","title":"Stage 2 Re-Randomized AMC","description":"Those participants who were randomized to the Placebo arm in Stage 1 (Week 1) and were deemed Non-Responders at Study Weeks 5-6 and were re-randomized to the Active Medication Combination arm in Stage 2 (Week 7)","deathsNumAffected":0,"deathsNumAtRisk":114,"seriousNumAffected":3,"seriousNumAtRisk":114,"otherNumAffected":32,"otherNumAtRisk":114},{"id":"EG004","title":"Stage 2 Not Re-Randomized Placebo","description":"Those participants who were originally randomized to the Placebo arm in Stage 1 (and may or may not have been deemed Non-Responders at Study Weeks 5-6) and were not Re-Randomized, so they remained in the Placebo arm throughout the study (Weeks 1-12).","deathsNumAffected":0,"deathsNumAtRisk":69,"seriousNumAffected":1,"seriousNumAtRisk":69,"otherNumAffected":0,"otherNumAtRisk":69},{"id":"EG005","title":"Stage 2 Not Re-Randomized AMC","description":"All participants who were randomized to the Active Medication Combination arm in Stage 1 (Week 1) remained in the AMC arm throughout the study (Weeks 1-12).","deathsNumAffected":0,"deathsNumAtRisk":109,"seriousNumAffected":3,"seriousNumAtRisk":109,"otherNumAffected":6,"otherNumAtRisk":109}],"seriousEvents":[{"term":"Seizure","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":294},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":109},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":111},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":114},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":69},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":109}]},{"term":"Substance-induced psychotic disorder","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":294},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":109},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":111},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":114},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":69},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":109}]},{"term":"Paranoia","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":294},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":109},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":111},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":114},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":69},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":109}]},{"term":"Gastroenteritis","organSystem":"Infections and 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